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Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial

Study acronym: CAN-CHA
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 29, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Phase: Phase 1 to Phase 2v6 Show 4 more changesShow less
    • Start date: Nov 27, 2023 to Oct 11, 2024
    • Eligibility criteria expanded, about 46 words
    • Study sites revised (3)
    • Collaborators: 2 to 1
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2023 to Nov 27, 2023
    • Secondary endpoints: details revised at 1 of 9 entries
    • Site details revised at 3 of 3 sites
    v5
  3. Start date: Feb 1, 2023 to Jul 1, 2023
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 8 to 9
    v4
  4. Interventions: CBD50 plus (Drug) to MPL-001 (Drug)v3
  5. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025
    • Start date: Jul 1, 2022 to Feb 1, 2023
    • Interventions: LGP1:20 (Drug) to CBD50 plus (Drug)
    • Collaborators revised (2)
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.
Trial Details
NCT Number NCT05337033
Lead Sponsor University of Manitoba
Collaborators: SickKids Foundation
Conditions
(from sponsor)		 Chronic Migraine
Related terms Marijuana Abuse, Migraine Disorders
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov